HPLC法测定复方氨酚苯海拉明片中对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明的含量

目的建立同一色谱条件测定复方氨酚苯海拉明片中的对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明含量的HPLC法。方法采用苯基柱(4.6 mm×250 mm,5μm),流动相为甲醇-pH 3.5的10 mmol.L-1乙酸铵溶液(体积比85∶15),检测波长为225 nm。结果对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明的分离度好,对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明的回收率分别为100.1%、100.0%、100.2%和100.6%(n=9)。结论本方法操作简单,结果准确,可以有效地控制复方氨酚苯海拉明片的质量。

Simultaneous determination of paracetamol,caffeine,ephedrine hydrochloride and diphenhydramine hydro-chloride in compound paracetamol and diphenhydra-mine hydrochloride tablets by HPLC

Objective To establish a method for determining the compound paracetamol and diphenhydramine hydrochloride tablets by HPLC.Methods Phenyl column was used and methanol-10 mmol·L-1 pH3.5 ammonium acetate buffer(V∶V=85∶15) was selected as mobile phase;the wavelength of detector was set at 225 nm.Results Paracetamol,caffeine,ephedrine hydrochloride and diphenhydramine hydrochloride were well separated.The average recoveries were 100.1%,100.0%,100.2% and 100.6%(n=9),respectively.Conclusions This method is simple,accurate and convenient.It is very suitable for the quality control of the compound paracetamol and diphenhydramine hydrochloride tablets.